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Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)

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ClinicalTrials.gov Identifier: NCT03768427
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 29, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date September 2, 2019
Actual Study Start Date  ICMJE May 27, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Percent Change from Baseline in LDL-C at Week 12 (Cohort A) [ Time Frame: Baseline and Week 12 ]
    Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
  • Percent Change from Baseline in LDL-C at Week 12 (Cohort B) [ Time Frame: Baseline and Week 12 ]
    Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03768427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Number of Participants with An Adverse Event (AE) [ Time Frame: Up to 14 weeks ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group with at least one AE was assessed over 12 weeks of treatment with MK-0653C, plus 14 days (2 weeks) of follow-up.
  • Number of Participants Who Discontinued From Study Treatment [ Time Frame: Up to 12 weeks ]
    The number of participants who discontinued treatment over the 12-week treatment period was assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
Official Title  ICMJE A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowing Treatment in Chinese Participants
Brief Summary This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Combination Product: EZ 10 mg/Ator 10 mg
    FDC of EZ10 mg/Ator 10mg
  • Combination Product: EZ 10 mg/Ator 20 mg
    FDC of EZ10 mg/Ator 20mg
  • Drug: Atorvastatin
    Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
    Other Name: Lipitor^®
  • Drug: Placebo for FDC EZ/Ator
    A single placebo tablet administered orally QD for 84 days
  • Drug: Placebo for atorvastatin
    Two placebo tablets matching atorvastatin administered orally QD for 84 days
Study Arms  ICMJE
  • Experimental: EZ 10 mg/Ator 10 mg
    Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
    Interventions:
    • Combination Product: EZ 10 mg/Ator 10 mg
    • Drug: Placebo for FDC EZ/Ator
  • Active Comparator: Atorvastatin 20 mg
    2 atorvastatin 10 mg tablets administered orally, QD for 84 days
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo for atorvastatin
  • Experimental: EZ 10 mg/Ator 20 mg
    Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
    Interventions:
    • Combination Product: EZ 10 mg/Ator 20 mg
    • Drug: Placebo for FDC EZ/Ator
  • Active Comparator: Atorvastatin 40 mg
    2 atorvastatin 20 mg tablets administered orally, QD for 84 days
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo for atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 26, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has hypercholesterolemia diagnosed by investigator according to Chinese Guidelines on Prevention and Treatment of Dyslipidemia in Adults (2016 Edition).
  • Has been stabilized on atorvastatin treatment at 10 mg or 20 mg (or other statins with LDL-C lowering efficacy equivalent to atorvastatin) for at least 4 weeks prior to Visit 1.
  • If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.
  • If male, has used a contraceptive consistent with local regulations.
  • Agrees to maintain a stable diet and stable exercise during the study.

Exclusion Criteria:

  • Has uncontrolled hypertriglyceridemia which needs drug intervention or a fasting triglyceride (TG) value ≥500 mg/dL (4.52 mmol/L).
  • Is currently treated with statin at dose of equivalent LDL-C lowering effect >20 mg atorvastatin.
  • Has active liver disease
  • Has New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure at Visit 1.
  • Has had uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, unstable angina, or stroke within 3 months (12 weeks) prior to Visit 1.
  • Has homozygous familial hypercholesterolemia or has undergone LDL apheresis.
  • Has endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hyper or hypothyroidism, Cushing's syndrome).
  • Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption.
  • Has a history of cancer within the past 5 years from Visit 1 (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer).
  • Is known to be human immunodeficiency virus (HIV) positive.
  • Has hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications or has a condition or situation, which is described as a contraindication in labeling of EZETROL or Lipitor or may interfere with participation in the study.
  • Has disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
  • Has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
  • Has a history of myopathy or rhabdomyolysis with ezetimibe or any statin.
  • Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Is currently taking medications that are potent modulators of cytochrome P-450 3A4 (CYP3A4) including: cyclosporine, systemically administered azole antifungals (e.g., ketoconazole, fluconazole, and itraconazole), macrolide antibiotics (e.g., clarithromycin, and erythromycin), protease inhibitors (e.g., ritonavir, saquinavir, and lopinavir), grapefruit or juice of grapefruit (200 ml/day for >3 times per week)
  • Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement therapy (HRT) or any estrogen antagonist/agonist within 8 weeks.
  • Note: If participant has been treated with a stable regimen of non-cyclical HRT for > 8 weeks and agree to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
  • Is receiving treatment with systemic corticosteroids (intravenous, intramuscular and oral steroids).
  • Is treated with psyllium, other fiber-based laxatives, phytosterol margarine, and herbal medicine and/or over the counter (OTC) therapies that are known to affect serum lipids.
  • Note: If participant has been treated with a stable regimen for > 8 weeks and agrees to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
  • Is treated with an anti-obesity drug (e.g. mazindol) within 12 weeks prior to Visit 1.
  • Is treated with warfarin or warfarin-like anticoagulants and has not been on a stable dose with a stable International Normalized Ratio (INR) for at least 6 weeks.

weeks.

  • Has taken lipid-lowering agents (except probucol) including, Cholestin, bile acid sequestrants, ezetimibe, fibrates or niacin (>200 mg/day), proprotein convertases subtilisin/kexin type 9 (PCSK9) inhibitors within 6 weeks prior to Visit 1.
  • Has taken probucol within 10 weeks prior to Visit 1.
  • Has been treated with any other investigational drug within 30 days.
  • Currently follows an excessive weight reduction diet.
  • Currently engages in a vigorous exercise regimen (e.g., marathon training, body building training) or intends to start training during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768427
Other Study ID Numbers  ICMJE 0653C-439
MK-0653C-439 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP